伊立替康联合顺铂对比伊立替康单药二线治疗晚期胃癌的临床研究

目的 探讨伊立替康（CPT-11）联合顺铂（DDP）方案与CPT-11单药治疗晚期胃癌的疗效、远期生存和毒副反应。方法 收集2012年6月至2014年1月复治晚期胃腺癌患者168例，随机分为CPT-11+DDP组（n=84）和CPT-11组（n=84）。CPT-11联合DDP方案：CPT-11 250 mg/m2静滴，d1；DDP 70 mg/m2静滴，d1，21天为1周期。CPT-11方案：CPT-11 250 mg/m2 d1静滴，21天为1周期。化疗2个周期后进行近期疗效评价，并比较两组的远期生存和不良反应。结果168例均可评价疗效。CPT-11+DDP组获CR 3例、PR 11例、SD 44例，有效率（RR）为167%，疾病控制率（DCR）为890%。CPT-11组获CR 1例、PR 12例、SD 41例，RR 为155%，DCR 为643%。两组RR和DCR的差异均无统计学意义（P=0834，P=0513）。CPT-11+DDP组和CPT-11组的无进展生存期分别为46个月和41个月（P=0522），中位总生存期分别为138个月和125个月（P=0185）。亚组分析显示，在肠型腺癌中CPT-11+DDP组的中位总生存期优于CPT-11组（156个月vs. 136个月，P=0.016）。CPT-11+DDP组3～4级贫血、肝功能损害以及1～4级肾功能损害的发生率高于CPT-11组，而CPT-11组1～4级便秘和口腔黏膜炎的发生率均高于CPT-11+DDP组，差异均有统计学意义（P<0.05）。结论 CPT-11联合DDP方案较单药CPT-11方案二线治疗晚期胃癌并未带来生存获益，但对于晚期肠型胃癌具有优势，且安全性良好，值得进一步深入观察。

Clinical study of irinotecan plus cisplatin regimen versus irinotecan alone as second-line chemotherapy for advanced gastric cancer

Objective To investigate the therapeutic effect， long term survival and side effects on advanced gastric cancer patients treated with irinotecan（CPT-11） plus cisplatin（DDP） regimen and CPT-11 alone as second line chemotherapy. Methods A total of 168 gastric cancer patients enrolled from June 2012 to January 2014 failed in first line chemotherapy were randomly allocated to CPT-11+DDP group（CPT-11 250mg/m2 iv， d1； DDP 70 mg/m2 iv， d1， 21 days as a cycle） or CPT-11 group（250 mg/m2 iv，d1，21 days as a cycle） with 68 cases in each group. Short-term efficacy was evaluated after 2 cycles’ therapy， and long-term efficacy， as well as side effects was compared between both groups. Results Efficacy could be evaluated in 168 cases. In CPT-11+DDP group，there were 3 cases in CR， 11 in PR， 44 in SD， and the response rate（RR） and disease control rate（DCR） were 167% and 890%. In CPT-11 group， there were 1 case in CR， 12 in PR， 41 in SD，and RR, DCR were 155% and 643%. The difference of RR and DCR had no significance between both groups（P=0.834， P=0.513）. The median progression free survival were 4.6 and 4.1 months in CPT-11+DDP group and CPT-11 group（P=0.522）， and the median overall survival（OS） were 13.8 and 12.5 months， respectively（P=0.185）. The incidences of grade 3-4 anemia， grade 3-4 liver impairment and grade 1-4 kidney impairment were higher in CPT-11+DDP group than in CPT-11 group（P<0.05）. The incidences of grade 1-4 constipation and mucositis were lower in CPT-11/DDP group than in CPT-11group（P<0.05）. Subgroup analysis revealed that the median OS of CPT-11/DDP group was significantly better than that of CPT-11 group（15.6 months vs. 13.6 months， P=0.016）. Conclusion Compared with CPT-11monotherapy，CPT-11/DDP regimen shows no survival benefit as second-line treatment for advanced gastric cancer. However， intestinal type of gastric cancer can benefit from CPT-11/DDP regimen，and side effects are well tolerated，worthy of further observation.